Characterization of Cleft Lip and Palate Conditions in Guatemala

Completed

• Conditions: Cleft Lip; Cleft Lip and Palate; Cleft Palate
• Interventions: Other: NA - survey instrument

• Registration Number: NCT04725370
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.

Detailed Description

Demographic, surgical, and cleft type data from US patients were gathered via chart review of the electronic medical record. Data from Guatemalan patients was gathered orally from patient caregivers in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Study Timeline

• Study Start: 2017-10-30
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2021-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

• diagnosis of isolated cleft lip and/or palate
• scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames

Exclusion Criteria

• diagnosis of a recognized medical syndrome
• medically complex defined as having major medical problems in three or more organ systems
• diagnosis of isolated midline cleft lip
• diagnosis of Tessier facial cleft
• greater than 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SFG (Guatemala)	NA - survey instrument	Children with isolated cleft lip and/or cleft palate scheduled for surgery between 2017 and 2020 with Smiles for Guatemala, Guatemala City, Guatemala.

Primary Outcome Measures

Name	Time	Method
Cleft phenotype	pre-surgery	Presence, laterality, and completeness of cleft lip and/or palate as classified by the LAHSHAL system, data gathered by physical exam

Secondary Outcome Measures

Name	Time	Method
Surgical care	pre-surgery	Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review
Cleft risk factors	during the surgery	Presence of potential risk factors for cleft lip and palate such as maternal exposures during pregnancy, data gathered by interview with caregivers

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States